Schizochytrium sp. oil: authorised novel food in the EU

Conditions of use and maximum levels

Table 1, column "Conditions under which the novel food may be used", as written:

• Dairy products except milk-based drinks: 200 mg/100 g or for cheese products 600 mg/100 g
• Dairy analogues except drinks: 200 mg/100 g or for analogues to cheese products 600 mg/100 g
• Spreadable fat and dressings: 600 mg/100 g
• Breakfast cereals: 500 mg/100 g
• Food Supplements as defined in Directive 2002/46/EC: 250 mg DHA/day for general population
• Food Supplements as defined in Directive 2002/46/EC: 450 mg DHA/day for pregnant and lactating women
• Total diet replacement for weight control as defined in Regulation (EU) No 609/2013 and meal replacements for weight control: 250 mg/meal
• Milk-based drinks and similar products intended for young children: 200 mg/100 g
• Processed cereal-based foods and baby foods for infants and young children as defined in Regulation (EU) No 609/2013: 200 mg/100 g
• Foods intended to meet the expenditure of intense muscular effort, especially for sportsmen: 200 mg/100 g
• Foods bearing statements on the absence or reduced presence of gluten in accordance with the requirements of Implementing Regulation (EU) No 828/2014: 200 mg/100 g
• Foods for special medical purposes as defined in Regulation (EU) No 609/2013: In accordance with the particular nutritional requirements of the persons for whom the products are intended
• Bakery products (breads, rolls, and, sweet biscuits): 200 mg/100 g
• Cereal bars: 500 mg/100 g
• Cooking fats: 360 mg/100 g
• Non-alcoholic beverages (including dairy analogue and milk-based drinks): 80 mg/100 ml
• Fruit/vegetable puree: 100 mg/100 g

Additional specific labelling requirements

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Oil from the microalgae Schizochytrium sp.’

Specification (Table 2)

Table 2 of the Annex, row with the same name, as written:

Acid value: ≤ 0,5 mg KOH/g

Peroxide value (PV): ≤ 5,0 meq/kg oil

Moisture and volatiles: ≤ 0,05 %

Unsaponifiables: ≤ 4,5 %

Trans-fatty acids: ≤ 1,0 %

DHA content: ≥ 32,0 %

Source and version

Implementing Regulation (EU) 2017/2470, Annex, Union list of novel foods, Table 1. Consolidated text of 10 August 2026. The text above is copied from that document without change except that amendment markers are removed. It is not advice and it does not decide whether a particular product is covered.

• Consolidated text on EUR-Lex

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